DiabetesPhase 1NCT01527630
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects
A Phase 1 study testing biphasic insulin aspart 50 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart 50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 16 Nov 2002to 8 Jan 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
- Body Mass Index (BMI) between 19-29 kg/m^2 (inclusive)
- Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)
Who cannot join
- Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
- Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
- Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
- Hepatitis B or C, or HIV (human immunodeficiency virus) positive
- Subjects with a first degree relative with diabetes mellitus
- History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
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- Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse
- Subjects who smoked more than 5 cigarettes per day
- Subjects who had taken part in strenuous exercise within 7 days prior to the screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 50
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biphasic insulin aspart 50Drug
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | Not described Receives: Drug: biphasic insulin aspart 50 |
| Formulation B | Experimental | Not described Receives: Drug: biphasic insulin aspart 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours
Cmax, maximum insulin aspart concentration
Secondary outcomes (4)
Area under the insulin aspart concentration-time curve
Tmax, time to maximum insulin aspart concentration
MRT, mean residence time
t½, terminal half-life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study start16 Nov 2002
- Primary completion8 Jan 2003
- Study completion8 Jan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527630
- Sponsor's protocol ID
- BIASP-1504
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2012
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01527630
- Acronym / sponsor ID
- BIASP-1504
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2002 (actual)
- Primary completion
- 8 Jan 2003 (actual)
- Study completion
- 8 Jan 2003 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: biphasic insulin aspart 50 |
| Formulation B | Experimental | Drug: biphasic insulin aspart 50 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
- Body Mass Index (BMI) between 19-29 kg/m^2 (inclusive)
- Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)
Key exclusion criteria (9 listed)
- Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
- Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
- Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
- Hepatitis B or C, or HIV (human immunodeficiency virus) positive
- Subjects with a first degree relative with diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biphasic insulin aspart 50A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days | Drug | Formulation A, Formulation B |
Primary outcome
Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours
Cmax, maximum insulin aspart concentration
4 secondary outcomes
Area under the insulin aspart concentration-time curve
Tmax, time to maximum insulin aspart concentration
MRT, mean residence time
t½, terminal half-life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing biphasic insulin aspart 50 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.